Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 0143-9331
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Intracaudal, Perineural · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9331-10 | 00143933110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9331-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9331-01)Marketed from Feb 11, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bupivacaine Hydrochloride
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Intracaudal, Perineural
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204842
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0143-9331_1f5e723d-d695-4460-8142-713a5d621cffSPL ID 1f5e723d-d695-4460-8142-713a5d621cffSPL set ID 8815c8c6-eed8-4afe-a5c1-44d2194025a3RxCUI 1724786, 1724787, 1724880, 1724884, 1725078, 1725082UNII 7TQO7W3VT8
- Pharmacologic class
- Amide Local Anesthetic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400143933110followed by a unit qualifier and the quantityPackage 00143-9331-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Bupivacaine Hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precau…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204842
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9330 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Hikma Pharmaceuticals USA Inc. | 0143-9332 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9333 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9334 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Hikma Pharmaceuticals USA Inc. | 0143-9335 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Asclemed USA, Inc. | 76420-561 |